NCT01812382

Retapamulin Microdialysis Feasibility Study

A Study to Evaluate the Feasibility of Microdialysis to Determine Skin Concentrations of Retapamulin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects will be enrolled and complete the study procedures. Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure. After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection will continue every 30 minutes for 4 hours. The approximate duration of study including follow-up is 4 days.

Conditions

• Skin Infections, Bacterial

Interventions

Type	Name	Description
DRUG	Retapamulin Microdialysis	After a 30 minutes equilibration period of the microdialysis procedure/infusion with normal saline solution, 50nanogram (ng)/mL Retapamulin injectable solution will be infused at a flow rate of 1.5 microliter/minute over a period of 90 minutes. The total dose perfused for each of the 3 microdialysis tubes will be 6.75ng.

Timeline

• Start date: 2014-04-02
• Primary completion: 2014-05-27
• Completion: 2014-05-27
• First posted: 2013-03-18
• Last updated: 2017-05-15

Locations

1 site across 1 country: United States